Kornimate/medical-research-clean huggingface dataset:
an observational study of tarceva (erlotinib) in first line in patients with advanced egfr mutation-positive non-small cell lung cancer (gertac)

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: this observational study will evaluate the efficacy and safety of tarceva (erlotinib) in first-line therapy in patients with locally advanced or metastatic egfr mutation-positive non-small cell lung cancer. eligible patients, for whom the treating physician has decided to initiate treatment with tarceva according to the local label will be followed for 18 months.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * locally advanced or metastatic egfr mutation-positive non-small cell lung cancer * patients for whom the treating physician has decided to initiate first-line therapy with tarceva in accordance with the summary of product characteristics and local guidelines exclusion criteria: * n/a
a study of at13387 in patients with non-small cell lung cancer (nsclc) alone and in combination with crizotinib

Conditions: Non-small Cell Lung Cancer(NSCLC)

Summary: the purpose of the study is to evaluate safety and efficacy of at13387 alone and in combination with crizotinib in the treatment of non-small cell lung cancer.

this is a 3-part phase 1-2 study in patients with anaplastic lymphoma kinase (alk) + or other potentially crizotinib-sensitive nsclc who have been receiving crizotinib. part a is a single-arm, phase 1, open-label, dose escalation design in patients with nsclc who have already been receiving crizotinib for at least 8 weeks and continue to tolerate therapy. part b is a phase 2, open-label, randomized continuation design comparing crizotinib alone versus the combination of crizotinib + at13387 at the maximum tolerated dose established in part a. part c is an open-label, randomized, phase 2, simon's 2 stage design evaluating single agent at13387 or combination at13387 + crizotinib at the mtd established in part a in patients who progressed on crizotinib at any time.

Eligibility criteria:
inclusion criteria: 1. men or women 18 years of age or older 2. must have non-small cell lung cancer with alk+ mutation or other mutations or rearrangements potentially sensitive to crizotinib 3. measurable disease 4. must have been receiving or have received crizotinib 5. have adequate cardiac, bone marrow, liver and kidney function 6. must be willing and able to provide written informed consent and comply with the protocol and study procedures exclusion criteria: 1. prior anti-cancer treatment with any hsp90 inhibitor 2. have received chemotherapy, radiation therapy or other anticancer treatment other than crizotinib within 3 weeks prior to the first dose of study drug 3. prior malignancy other than adequately treated basal or squamous cell carcinoma of the skin, superficial bladder cancer, low-grade cervical cancer, non-metastatic prostate cancer, or have been disease-free for at least 3 years 4. abnormal heart function 5. presence of a life-threatening illness, medical condition, organ system dysfunction, or other factors 6. hypersensitivity of at13387 or other components of the drug product 7. treatment with an investigational drug within 3 weeks prior to the first dose of study drug 8. severe systemic diseases or active uncontrolled infections 9. known history of human immunodeficiency virus (hiv) or seropositive test for hepatitis c virus or hepatitis b virus

Keywords: non-small cell lung cancer
high myopia: extended and longterm observation of pathologic myopia patients with the risk for developing a myopic choroidal neovascularization (cnv)

Conditions: Pathologic Myopia

Summary: this research project intends to observe patients with high myopia who show pathological retinal changes, in order to evaluate more data on the risk factors for developing mcnv within this research project population in germany.


Eligibility criteria:
inclusion criteria: * male or female caucasian patients ≥ 18 years of age * diagnosis of high myopia secondary to an anterior-posterior elongation of the bulbus confirmed by ocular examination in either eye using the following criteria: * ocular ultrasonography or biometry demonstrating anterior-posterior elongation measurement ≥ 26 mm * abnormal change in retinal tissue by sd-oct that are attributed to be caused by high myopia as shown in table 4-2 of the protocol in the investigator's discretion confirmed by the reading centre exclusion criteria: * patients with diabetes mellitus of any grade * patients showing signs of age-related macular degeneration (amd), e.g. drusen, characteristic changes in fundus (with shaping or extension of hemorrhages, fibrosis, exudative areas) in either eye * acute neovascularization (cnv or iris neovascularization) and intra- or subretinal fluid in either eye at the time of enrolment. * history of inactive cnv in study eye. inactive cnv of fellow eye is allowed if treatment was performed more than 12 months before enrolment. * any anti vascular endothelial growth factor' (anti-vegf) or verteporfin treatment in study eye and anti-vegf or verteporfin treatment less than 12 months before enrolment in fellow eye * history of systemic anti vascular endothelial growth factor' (anti-vegf) therapy * cataract that would prevent an accurate measurement of the axial length of the study eye other protocol-defined inclusion/exclusion criteria may apply

Keywords: high myopia, shortsightedness, retinal changes
aripiprazole (abilify®) as an adjunctive treatment for inadequate response in major depressive disorder

Conditions: Major Depressive Disorder

Summary: the investigators hypothesized that combined pharmacotherapy using adjunctive aripiprazole of standard antidepressants would be associated with improved depression response in major depressive disorder, especially in quality of life. the investigators compare the mean changes in the quality of life between before add-on and 8 weeks treatment of aripiprazole and between before add-on and 6 weeks treatment of aripiprazole.

previous study about quality of life measurement in patients with depression have been reported that quality of life have to be measured irrespective with the severity of depression because quality of life has some other aspect to depression.the investigators have designed a 6-week single blinded study with flexible dose aripiprazole augmentation, ranging from 2.5mg to maximum 20 mg (15mg for patients on fluoxetine or paroxetine), in patients who responded inadequately (a score of \>18 on the madrs) to first-line antidepressant pharmacotherapy. the investigators compare the mean changes from in the quality of life at 8 weeks.

Eligibility criteria:
inclusion criteria: * age : 18-65 * patients with major depressive disorder according to dsm-iv criteria that have lasted \>8 weeks * madrs total score of 18 or higher * patients who responded inadequately (a score of \>18 on the madrs) to first-line antidepressant treatment of 4 week duration * current use of standard antidepressant treatment in monotherapy or combination of 2 antidepressants : escitalopram (10 - 20mg/d), fluoxetine(20 - 40mg/d), paroxetine cr(25 - 50mg/d), sertraline(100 - 150mg/d), mirtazapine (15 - 45mg/d), duloxetine (30 - 60mg/d) or venlafaxine er(150-225mg/d) exclusion criteria: * past history of hypersensitivity to aripiprazole * primary diagnosis of mdd with psychotic feature, bipolar disorder, schizophrenia, schizoaffective disorder, other psychotic disorder or anxiety disorder, a history of alcohol/ drug abuse within the past 12 months, or a diagnosis of dementia * clinically significant current axis ii (dsm-iv-tr) diagnosis * a significant risk of suicide corroborated by a score of ≥5 on item 10(suicidal thoughts) on the madrs scale or by clinical judgment of the investigator * pregnancy or in breast-feeding * presence of a serious medical illness including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic, or hematologic disease or physical disorder judged to significantly affect central nervous system function * patients taking antipsychotics, mood stabilizer or any psychotropic medications besides antidepressants, except benzodiazepines or beta blockers or hypnotics * patients with past treatment failures of aripiprazole
a phase i study to evaluate the safety and drug allergy of hlb3-002 in healthy volunteers

Conditions: Healthy

Summary: part i) multi-center, randomized, double-blind, placebo controlled part ii) multi-center, randomized, double-blind, placebo controlled


Eligibility criteria:
inclusion criteria: \[part i\] 1. healthy volunteers aged 19 years or older at the time of screening (visit 1). 2. subjects with intact skin at the site of administration, without tattoos, acne, dermatitis, pigmentation, or lesions that could interfere with the administration of the investigational drug and allergy testing. \[part ii\] 1. subjects who tested negative on the drug allergy assessment after part 1 intradermal administration. 2. for women of childbearing potential, a negative pregnancy test (serum-hcg) at baseline visit (v5). exclusion criteria: \[part i\] 1. subjects with the following comorbidities or conditions: * acute fever exceeding 37.5°c within 1 week prior to the baseline (visit 2). * symptoms of an acute illness within 2 weeks prior to the baseline (visit 2). * immune disorders that may affect the immune system (e.g., flu, cancer, hiv). * chronic urticaria, dermographism. * clinically significant diseases affecting the liver, kidneys, gastrointestinal system, cardiovascular system, respiratory system, endocrine system, immune system, psychiatric/neuropsychiatric system, hematologic system, or oncology. * clinically significant blood pressure abnormalities. * hypertension: systolic blood pressure ≥140 mmhg and/or diastolic blood pressure ≥90 mmhg. * hypotension: systolic blood pressure ≤90 mmhg and/or diastolic blood pressure ≤60 mmhg. 2. subjects who have smoked more than 10 cigarettes per day within 4 weeks prior to the screening (visit 1). 3. subjects who have participated in another clinical trial and received investigational drugs or medical devices within 6 months prior to the baseline (visit 2). 4. other subjects deemed inappropriate for participation in this clinical trial by the investigator. \[part ii\] 1) subjects with the following comorbidities or conditions: * acute fever exceeding 37.5°c within 1 week prior to the baseline (visit 5). * symptoms of an acute illness within 2 weeks prior to the baseline (visit 5). * clinically significant diseases affecting the liver, kidneys, gastrointestinal system, cardiovascular system, respiratory system, endocrine system, immune system, psychiatric/neuropsychiatric system, hematologic system, or oncology. * clinically significant blood pressure abnormalities. * hypertension: systolic blood pressure ≥140 mmhg and/or diastolic blood pressure ≥90 mmhg. * hypotension: systolic blood pressure ≤90 mmhg and/or diastolic blood pressure ≤60 mmhg.
digital training module for sustainable education of pediatric oncology nurses

Conditions: Pediatric Cancer

Summary: pediatric oncology nurses are healthcare professionals who constantly communicate with children and their families for 24 hours, and take professional roles and responsibilities in areas such as care planning, a continuation of treatment, and symptom management.however, there is no standard undergraduate education program accepted worldwide in the field of pediatric oncology nursing. for example, undergraduate nursing education in türkiye is carried out in line with the nursing national core education program (nncep), and information about pediatric oncology nursing is included in the curriculum of specific courses in undergraduate programs. in addition, nurses graduate without specializing in any field in our country. therefore, the education of pediatric oncology nurses and the continuity of education is an essential problem in developing and low-middle-income countries like our country. this prospective study in randomized controlled pre-test-post-test design aimed to develop an online website consisting of information and support modules for the care of children with cancer for sustainable pediatric oncology nursing education in türkiye.

in developed countries, there are various programs for pediatric oncology nurses to improve the quality of nursing care. unfortunately, the inadequacy of these education programs in developing countries may prevent childhood cancer patients from receiving advanced care but may cause health inequalities. for this reason, it is very important to strengthen pediatric oncology nurses in terms of education and to develop platforms that will provide education continuity in low and middle-income countries. today, one of the methods used to ensure the continuity and easy accessibility of education is digital education programs. web-based education programs can increase nurses' knowledge and competence in related care issues. in studies, nurses state that planned educations were beneficial and increased their knowledge level. an accessible and sustainable web-based standard education program will enable nurses to become more competent in pediatric oncology and increase the quality of care. in türkiye, which is a middle-income country, there is no standard curriculum for pediatric oncology nurses. although pediatric oncology nursing is partially included in the oncology nursing certification program by the oncology nursing association, we could say that it is insufficient to meet nurses' sustainability and educational needs. therefore, there is a need for a digital website consisting of information and support modules to care for children with cancers for sustainable pediatric oncology nursing education in türkiye.

Eligibility criteria:
inclusion criteria: * volunteer to participate in the research, * working in a pediatric oncology clinic, * having at least one year of experience in pediatric oncology. exclusion criteria: * lack of internet literacy, * incomplete filling of data collection forms.

Keywords: education nursing development pediatric oncology
a single-arm, virtual clinical trial to evaluate the effects of a sleep supporting beverage and two coffee substitute products

Conditions: Sleep; Mood; Caffeine Withdrawal; Anxiety; Productivity

Summary: this is a virtual, single-arm clinical trial that will last 12 weeks. participants will trial three different products, each for 4 weeks. participants will trial clevr blends sleeptime during weeks 1-4, clevr matcha for weeks 5-8, and clevr blends chai for weeks 9-12. participants will complete questionnaires at baseline and week 2, 4, 6, 8, 10, and 12. in addition to data will be collected from participants' sleep tracking devices at baseline, week 2, and week 4.


Eligibility criteria:
inclusion criteria: * female. * age 28-42. * generally healthy without any uncontrolled or chronic disease. * must consume a beverage containing low to moderate amount of caffeine once daily, defined as consuming the caffeine equivalent of less than or equal to one cup of coffee daily. * looking for healthier alternatives to caffeine. * currently owns a wearable sleep tracking device (e.g. fitbit, whoop, oura etc) and has been wearing consistently for 4 weeks. * resident of the usa. exclusion criteria: * allergies to any of the ingredients in the three products. * anyone with a formal diagnosis of insomnia. * any pre-existing or chronic conditions that would prevent participants from adhering to the protocol. * women that are pregnant, breastfeeding or attempting to conceive during the duration of the trial. * unwilling to follow the protocol. * participants that consume more than two caffeinated drinks daily. * participants that have little to no caffeine daily, equivalent to less than 1 cup of coffee daily. * is not a resident of the usa.
a multicenter assessment of ald403 in chronic migraine

Conditions: Migraine Disorders

Summary: the purpose of this study is to assess ald403 in the prevention of migraine headache in chronic migraineurs.


Eligibility criteria:
inclusion criteria: * diagnosis of migraine at ≤ 35 years of age with history of chronic migraine ≥ 1 year * during the 28 day screening period, must have ≥ 15 headache days of which ≥ 8 days were assessed as migraine days with at least 5 migraine attacks as recorded in the ediary * headache ediary was completed on at least 22 of the 28 days prior to randomization exclusion criteria: * confounding pain syndromes (e.g. fibromyalgia, chronic low back pain, complex regional pain syndrome) or any pain syndrome that requires regular analgesia * psychiatric conditions that are uncontrolled and untreated, including conditions that are not controlled for a minimum of 6 months prior to screening. * history or diagnosis of complicated migraine (ichd-iii beta version, 2013), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, migraine with brainstem aura, sporadic and familial hemiplegic migraine * unable to differentiate migraine from other headaches * subject has received botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections in the head, face, or neck within 4 months prior to screening. * have any clinically significant concurrent medical condition * receipt of any monoclonal antibody treatment within 6 months of screening (within or outside a clinical trial) * previously dosed with ald403 or any monoclonal antibody targeting the cgrp pathway

Keywords: migraine disorders ald403
intraoperative hyperspectral imaging for laparoscopic surgery

Conditions: Colorectal Neoplasms; Colorectal Surgery; Cholecystitis; Cholecystectomy, Laparoscopic

Summary: the study aims to evaluate the use of the hypersnap surgical system (hss1) during laparoscopic surgeries, specifically in bowel resections and cholecystectomies.

the study will observe patients undergoing bowel resection and cholecystectomy surgeries to determine if hypersnap surgical system (hss1), as a primary visualisation tool, functions safely and capably as a laparoscopic imager. in addition, we will see if it subjectively improves the identification of critical anatomical structures. in addition, the study will secondarily assess how sto2 information may be included in the surgical workflow and how surgeons may react to this additional information.

Eligibility criteria:
inclusion criteria: a) cholelithiasis or cholecystitis with indications for laparoscopic surgery (cholecystectomy) * adult patients aged 18 years and over * common bile duct diameter \< 8mm as assessed using ultrasound * patients able to provide written informed consent b) colorectal cancer requiring elective bowel resection via a laparoscopic approach. * adult patients aged 18 years and over * patients who are scheduled for elective laparoscopic colon cancer resection * patients able to provide written informed consent exclusion criteria: a) cholelithiasis or cholecystitis with indications for laparoscopic surgery (cholecystectomy) * patients under 18 years of age * patients with a history of previous abdominal surgery and multiply scarred abdomen * common bile duct diameter ≥ 8mm as assessed using ultrasound * patients unable to provide written informed consent * patients who are pregnant b) colorectal cancer requiring elective bowel resection via a laparoscopic approach. * patients under 18 years of age * patients with a history of previous abdominal surgery and multiply scarred abdomen * patients unable to provide written informed consent * patients undergoing emergency surgery * patients who are pregnant

Keywords: hyperspectral imaging surgery laparoscopic surgery colorectal cancer cholecystitis
the value of cardiovascular imaging in kawasaki disease

Conditions: Kawasaki Disease

Summary: the goal of this observational study is to assess the cardiovascular injury of kawasaki disease with multi-modal imaging combined with clinical data. during their disease progress, participants will undergo cardiovascular magnetic resonance, echocardiography, electrocardiography, laboratory tests, and genetic tests when hospitalization and follow-up, and the baseline data will be collected at the admission. some patients will undergo coronary computed tomography angiography (ccta) or dsa due to the disease progress. all the above examination data and changes will be analyzed to assess the value of cardiovascular imaging in the pathogenesis, diagnosis, and prognosis of kawasaki disease.


Eligibility criteria:
inclusion criteria: * patients diagnosed based on the american heart association guideline for kawasaki disease. exclusion criteria: * patients with a history of congenital heart disease, cardiomyopathy. * patients with age over 18 years old.
the effectiveness of lsvt-big training in improving balance and gait in parkinson's patients

Conditions: Parkinson Disease

Summary: parkinson's disease (pd) is a chronic, progressive disease that causes motor and non-motor symptoms due to dopaminergic neuron loss. today, the treatment of pd in addition to optimal medical and surgical treatments, physiotherapy and rehabilitation approaches have an important place in the treatment. recently, it has been stated that intensive rehabilitation interventions in the field of physiotherapy and rehabilitation can be more effective than traditional rehabilitation approaches. lee silverman voicetreatment- big (lsvt-big) is a high-intensity exercise model aimed at improving bradykinesia and hypokinesia in pd. there are many studies showing improvements in balance, walking, motor performance, reaching ability, postural control, quality of life and cognitive status after lsvt-big training in pd. however, it is seen that there is no study investigating the effect of lsvt-big training directly by applying it as a home program. for this reason, there is a need for studies investigating whether this intensive treatment method can be an alternative to the clinical environment by applying it as a home program.

this study is planned as a randomized control trial. patients will be randomly divided into two groups a clinical group and a home group. the clinical group will be received lsvt-big training four times a week for four weeks in the clinic. the home group will be received lsvt-big training two times a week for four weeks at the home and two times a week for four weeks at the clinical. all assessments will be done before and after the 4-week intervention program or waiting period. the demographic characteristics of the participants initially will be taken. the outcome measures are balance and gait assessments.

Eligibility criteria:
inclusion criteria: * 18-80 years of age * having diagnosed with "parkinson's disease" by a specialist physician * having between 1-3 stages according to the hoehn and yahr scale * mini-mental test score more than or equal 24 exclusion criteria: - any orthopedic, vision, hearing, cardiovascular, or perception problems that may affect the research results

Keywords: parkinson disease lsvt-big training home based exercise balance walking
using probiotics to reactivate tumor suppressor genes in colon cancer

Conditions: Colon Cancer

Summary: the purpose of the study is to determine if probiotic bacteria have a beneficial effect on the colon cancer-associated microbiota and epigenetic alterations in colon cancer. dietary supplementation consists of two probion clinica tablets, yielding a daily dose of 1.4 x 10 ˄ 10 bifidobacterium lactis bl-04 (atcc sd5219), 7x10 ˄ 9 lactobacillus acidophilus ncfm (atcc 700396), and 0.63 g inulin.


Eligibility criteria:
inclusion criteria: * at least one malignant tumor in the colon exclusion criteria: * study subjects with adenomas, or * who received recent antibiotic therapy or * consumed probiotics regularly were excluded.

Keywords: probiotics epigenetics microbiota